Hereditary Spastic Paraplegia
Conditions
Brief summary
Hereditary spastic paraplegia (HSP) is a rare neurological condition that causes stiffness, weakness, and difficulty walking due to damage in the nerves that control movement. This study will test whether a noninvasive form of spinal cord stimulation, called transcutaneous spinal cord stimulation (tSCS), can improve walking and reduce muscle stiffness in adults with HSP. In this study, participants will receive tSCS twice a week for 8 weeks. The stimulation is delivered through self-adhesive electrodes placed on the skin over the lower back and does not require surgery. Each session will last about one hour. After the treatment period, participants will be followed for an additional 8 weeks without stimulation to see whether any improvements are maintained. Researchers will measure walking speed, walking endurance, muscle stiffness, and overall disease severity. Additional tests will explore changes in bladder and bowel function and muscle strength.
Interventions
DEVICEtranscutaneous spinal cord stimulation
a non-invasive spinal neuromodulation system will deliver stimulation as high-frequency pulsed current using frequencies within a predefined range
Sponsors
Rahul Sachdeva
Spastic Paraplegia Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available). * Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment. * Able to participate in study visits and assessments with or without assistive devices. * If ambulatory: able to walk at least 10 meters with or without an assistive device. * If wheelchair user: able to perform seated mobility tasks and transfers required for assessments. * Capacity to provide informed consent and follow study procedures, with an ability to communicate and understand instructions in English
Exclusion criteria
* Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps). * Severe cardiopulmonary disease that would make participation unsafe. * Open skin lesions or severe dermatologic conditions at electrode sites. * Pregnancy or plans to become pregnant during the intervention period. * Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a recent surgery on legs. * Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane). People who use wheelchairs or other mobility aids can participate if they can complete the study's mobility assessments in their usual way. * Cognitive or psychiatric conditions that make it difficult to give informed consent or follow study instructions. * Diagnosed with Urinary Tract Infection (UTI), either acute or ongoing, before or at the time of study enrollment. * Diagnosed with epilepsy. * Participation in another interventional clinical trial that could affect mobility or spasticity during the study. * A recent change (within the last 4 weeks) in medications or treatments that affect spasticity or movement (for example: baclofen, tizanidine, botulinum toxin injections). * Expect to start or change treatments for spasticity or mobility during the study period. * Any condition judged by the investigator to pose excess risk or confound outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10-Meter Walk Test (10MWT) | Baseline, Weeks 1, 4, 8, and 16 | 10MWT assesses walking speed over a 10-meter walkway at a comfortable and maximum safe pace. Timing occurs between 2 and 8 meters to exclude acceleration/deceleration, with two trials averaged per speed. Assistive devices are allowed |
| Change in 6- Minute Walk Test (6MWT) | Baseline, Weeks 1, 4, 8 and 16 | 6MWT evaluates walking endurance by measuring the total distance walked over six minutes. Patients are instructed to walk as far as possible at their own pace, with rests allowed if needed. The total distance reflects functional capacity and stamina, which are often affected in HSP due to progressive spasticity and weakness. |
| Change in Modified Ashworth Scale (MAS) | Baseline, Weeks 1, 4, 8, and 16 | measures muscle spasticity by assessing resistance to passive muscle stretch through the range of motion and grades the muscle tone on a 0-4 scale based on the resistance felt. MAS 0-4 scale: 0: No increased muscle tone 1: Slight increase in tone; catch and release at the end of the range 1+ : Slight increase; catch followed by minimal resistance through \< half the range 2: More marked increase through most of the range, but the limb still moves easily 3: Considerable increase in tone; passive movement is difficult 4: Limb is rigid in flexion or extension |
| Change in Spastic Paraplegia Rating Scale (SPRS) | Baseline, Weeks 1, 4, 8, and 16 | The Spastic Paraplegia Rating Scale (SPRS) is a validated clinical outcome measure used to assess disease severity in individuals with spastic paraplegia. The scale consists of 13 items evaluating gait, spasticity, muscle strength, coordination, and functional impairment. Each item is scored to yield a total score ranging from 0 to 52, where a score of 0 indicates no neurological disability and higher scores reflect increasing severity of impairment, with 52 representing the most severe disease manifestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HSP- Self Notion and Perception (HSP-SNAP) questionnaire | Baseline, Weeks 1, 4, 8, and 16 | HSP-SNAP is a questionnaire used to assess the self-perception of individuals diagnosed with hereditary spastic paraplegia (HSP). HSP-SNAP includes 12 questions, with 2 items dedicated to each symptom dimension (stiffness, weakness, imbalance, reduced endurance, fatigue, and pain). Each pair of items for a given dimension includes both positive and negative responses to prevent automatic answers. The HSP-SNAP employs a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). To account for both positive and negative items, scoring is as follows: for items with a positive tone, the score is calculated as "patient's score minus 1" (pt score-1); for negative items, the score is "5 minus the patient's score" (5-pt score). The overall score is the sum of all item scores, ranging from 0 to 48. A higher score indicates better well-being and milder symptoms. |
| Change in Joint Kinematics via Three-dimensional (3D) gait analysis | Baseline, Weeks 1, 4, 8, and 16 | 3D Gait Analysis will be performed using a 14-camera motion capture system, a wireless Electromyography (EMG) system, and 3 in-ground force plates. We will track walking speed using timing gates. Wireless EMG sensors will be placed on the vastus lateralis, rectus femoris, and vastus medialis to assess muscle activation during the gait trials. The outcomes will include joint kinematics (hip, knee, and ankle,). |
| Change in Sit-to-stand test | Baseline, Weeks 1, 4, 8, and 16 | Participants will be asked to perform a sit-to-stand task, whereby they will be told to stand up and sit down on a stool at their own self-selected pace. Sit-to-Stand performance, measured as the time and kinematic characteristics of sit-to-stand transition (average of two trials) obtained using motion capture analysis. |
| Change in Bilateral isometric knee strength | Baseline, Weeks 1, 4, 8, and 16 | Bilateral isometric knee strength will be obtained with three, 5-sec maximal voluntary isometric contractions (MVIC) separated by one-minute rest. Knee strength, measured as peak knee extensor torque obtained using isokinetic dynamometry (Biodex), expressed in Newton-meters (Nm), with higher values indicating greater muscle strength. |
| Change in knee pain | Baseline, Weeks 1, 4, 8, and 16 | Knee pain during knee strength test is recorded on an 11-point visual analog scale (0=no pain and 10 most pain possible). |
Countries
United States
Contacts
CONTACTRahul Sachdeva, PhD
PRINCIPAL_INVESTIGATORRahul Sachdeva, PhD
University of Kentucky
Outcome results
None listed